Sirius Engineering LLC

Sirius Engineering LLC is a medical device design, development, and manufacturing company specializing in product realization from concept through market launch. The firm operates an ISO 13485:2016-compliant quality management system and maintains FDA-aligned QSR protocols. Core capabilities include R&D, feasibility and qualification studies, design transfer, verification and validation testing, pilot and full-scale manufacturing, and warehousing/distribution. The company operates a certified ISO Class 7 cleanroom facility for sterile device production. Notable product examples include catheter systems (Cruzar Houdini for total occlusion crossing, Vortex for thrombus/emboli removal) and surgical closure devices (TAS Medical for minimally invasive hernia repair). The engineering team has contributed to over 200 patents and launched more than a dozen commercial products. Sirius Engineering serves medical device innovators and companies seeking end-to-end infrastructure for device development, regulatory submission preparation, manufacturing scale-up, and market delivery. The business model emphasizes partnership with inventors at any development phase, providing focused business development support alongside technical infrastructure. Facility: 4,100 square feet located on the San Francisco Bay Area Peninsula near Highway 101, between SFO and SJC airports.